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Reducing Sedentary Time in Patients With Heart Failure (Rest-HF)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reducing Sedentary Behavior
Physical Activity Group
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring sedentary time, number of steps/day, mobility, disability

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • NYHA II-IV,
  • Age ≥ 65,

  • SPPB score of > 4 and ≤ 10 of 12,

    • and deemed (by 1° cardiologist) to be at maximal tolerated dose of heart failure medication (ACE-inhibitor (ACE-I)/angiotensin receptor blocker and beta blocker (BB) for patients with HF with reduced ejection fraction (HFrEF), and
    • blood pressure controlled for HF with preserved ejection fraction (HFpEF) according to the American Heart Failure Association HF guidelines.

Exclusion Criteria:

  • Patients requiring medication titration such as ACE-I or BB, (will return to their cardiologist and be eligible after 3 months of stable medication.)
  • Oxygen dependent lung disease,
  • Orthopedic or neurologic disease that severely limits mobility,
  • Active cancer diagnosis except non-melanoma skin cancer,
  • Geriatric Depression Scale (GDS) score of ≥ 9 ,
  • Limited life-expectancy of <6 months,
  • Known dementia or disease that effects ability to learn/follow directions, or
  • Failed MiniCog test.

Sites / Locations

  • University of Colorado University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sedentary Group-Experimental

Physical Activity Group

Arm Description

The experimental group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to reduce sedentary time.

The Active Comparative group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to increase exercise time.

Outcomes

Primary Outcome Measures

Number of Subjects that are more active than Control.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2016
Last Updated
August 19, 2019
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02911493
Brief Title
Reducing Sedentary Time in Patients With Heart Failure
Acronym
Rest-HF
Official Title
Reducing Sedentary Time in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the change in sedentary time and number of steps/day for older patients with heart failure at risk for mobility disability who receive a program to decrease sedentary behavior versus a standard program to increase exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
sedentary time, number of steps/day, mobility, disability

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sedentary Group-Experimental
Arm Type
Experimental
Arm Description
The experimental group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to reduce sedentary time.
Arm Title
Physical Activity Group
Arm Type
Active Comparator
Arm Description
The Active Comparative group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to increase exercise time.
Intervention Type
Behavioral
Intervention Name(s)
Reducing Sedentary Behavior
Intervention Description
The experimental group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to reduce sedentary time.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Group
Intervention Description
The Active Comparative group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to increase exercise time.
Primary Outcome Measure Information:
Title
Number of Subjects that are more active than Control.
Time Frame
Monthly for 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: NYHA II-IV, Age ≥ 65, SPPB score of > 4 and ≤ 10 of 12, and deemed (by 1° cardiologist) to be at maximal tolerated dose of heart failure medication (ACE-inhibitor (ACE-I)/angiotensin receptor blocker and beta blocker (BB) for patients with HF with reduced ejection fraction (HFrEF), and blood pressure controlled for HF with preserved ejection fraction (HFpEF) according to the American Heart Failure Association HF guidelines. Exclusion Criteria: Patients requiring medication titration such as ACE-I or BB, (will return to their cardiologist and be eligible after 3 months of stable medication.) Oxygen dependent lung disease, Orthopedic or neurologic disease that severely limits mobility, Active cancer diagnosis except non-melanoma skin cancer, Geriatric Depression Scale (GDS) score of ≥ 9 , Limited life-expectancy of <6 months, Known dementia or disease that effects ability to learn/follow directions, or Failed MiniCog test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Boxer, MD, MSc
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado University
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Reducing Sedentary Time in Patients With Heart Failure

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